NCT07914439Completed
Inspiratory Muscle Training in Axial Spondyloarthritis
Impact of Inspiratory Muscle Training Plus Aerobic Exercise on Diaphragm Function, Disease Activity, and Sleep Quality in Axial Spondyloarthritis: A Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This study investigated the effects of inspiratory muscle training (IMT) combined with aerobic exercise on diaphragm function, disease activity, functional exercise capacity, fatigue, sleep quality, and health-related quality of life in patients with axial spondyloarthritis (AxSpA). Axial spondyloarthritis is a chronic inflammatory rheumatic disease that primarily affects the spine and sacroiliac joints. Reduced chest wall mobility and respiratory muscle function may contribute to decreased exercise capacity, fatigue, and impaired quality of life. This randomized controlled trial was conducted at Bursa Yuksek Ihtisas Training and Research Hospital, Türkiye, between May 2023 and March 2024. Forty-two male patients aged 18-60 years were randomly allocated to two groups. The control group received aerobic exercise and conventional spinal mobility exercises, while the intervention group received additional inspiratory muscle training using a respiratory resistance device. Both groups participated in a 12-week exercise program. Participants were assessed at baseline and after 12 weeks using diaphragm ultrasonography, disease activity measures, functional exercise tests, and validated questionnaires assessing fatigue, sleep quality, and quality of life. The study aimed to determine whether adding inspiratory muscle training to an aerobic exercise program provides additional clinical benefits for patients with axial spondyloarthritis.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 28 Oct 2026
- Start date
- 31 May 2023
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT07914439
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 31 May 2023 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Disease exacerbation or flare within the previous 3 months.
- Changes in pharmacological treatment within the previous 3 months.
Other illness
- Acute infection.
- Cardiopulmonary diseases.
- Endocrine diseases.
- Systemic diseases, including hepatic or renal failure.
- Neuromuscular disorders.
- Malignancy.
Other
- Spinal deformities.
- Orthopedic disabilities.
Who the study is looking for
- Male patients aged 18-60 years.
- Diagnosis of axial spondyloarthritis according to the 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria.
- Stable pharmacological treatment for at least 3 months prior to enrollment.
- Provision of written informed consent.
Age in the registry: 18 years to 60 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital Coordinator of this site? Confirm its status | Bursa | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.